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FDA 510(k)

FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON

K-Number: K021976 · 2002-10-25

ApplicantVital Scientific N.V.
Decision Date2002-10-25
Product CodeKQG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON is the device name listed in this FDA 510(k) record. The listed applicant is Vital Scientific N.V.. It received FDA 510(k) clearance on 2002-10-25 under 510(k) number K021976. The device is classified under product code KQG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON?

FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON is a medical device that received FDA 510(k) clearance on 2002-10-25. The listed applicant is Vital Scientific N.V.. The 510(k) number is K021976.

When did FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON receive FDA 510(k) clearance?

FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON received FDA 510(k) clearance on 2002-10-25, under 510(k) number K021976.

Who is the listed applicant for FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON?

The FDA 510(k) record lists Vital Scientific N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON?

The FDA product code for FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON is KQG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Vital Scientific N.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K022021VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTTK022046VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROLK020840VITAL SCIENTIFIC PT WITH CALCIUMK973628VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA

Related Devices (Code: KQG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K050821COAGCARE ANTICOAGULATION MANAGEMENT SYSTEMZycareK992130PACIFIC HEMOSTASIS THROMBOSCREEN 400CPacific HemostasisK991321PACIFIC HEMOSTASIS THROMBOSCREEN 200Pacific HemostasisK983475HEMOCHRON RESPONSEInternational Technidyne Corp.K902614ELVI 828 DIGICLOT MULTISCANLogos Scientific, Inc.K900685CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZERTexas Intl. Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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